Drug safety alert: Canagliflozin (Invokana, Invokamet) may increase the risk of leg and foot amputations

Access to the full content of this site is available only to registered healthcare professionals. Register to read more

ISSUE: Based on new data from two large clinical trials, the FDA has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. FDA is requiring new warnings, including the most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.

Final results from two clinical trials – the CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus) – showed that leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo, which is an inactive treatment. Amputations of the toe and middle of the foot were the most common; however, amputations involving the leg, below and above the knee, also occurred. Some patients had more than one amputation, some involving both limbs. See the FDA Drug Safety Communication for additional information, including a data summary.

BACKGROUND: This information is an update to the May 18, 2016 MedWatch safety alert. Canagliflozin is a prescription medicine used with diet and exercise to lower blood sugar in adults with type 2 diabetes. It belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Canagliflozin lowers blood sugar by causing the kidneys to remove sugar from the body through the urine. It is available as a single-ingredient product under the brand name Invokana and also in combination with...

Recommended for you

  • MedWatch Drug Updates
  • 1 comment

Class I Recall of HeartMate II LVAS Pocket System Controller by Abbott-Thoratec- Controller malfunction after exchange

Read more
  • MedWatch Drug Updates
  • no comment

Gadolinium-based contrast agent for MRI- No adverse effects reported with gadolinium retention in the brain

Read more
  • MedWatch Drug Updates
  • 1 comment

Class I Recall of V60 Non-invasive ventilator by Respironics- Unexpected stop in ventilation therapy

Read more
  • MedWatch Drug Updates
  • 1 comment

Recall of Tri-Ton by Dynamic Technical Formulations LLC- Presence of unapproved drug andarine and ostarine

Read more
  • MedWatch Drug Updates
  • no comment

Drug safety alert: Canagliflozin (Invokana, Invokamet) may increase the risk of leg and foot amputations

Read more
  • FDA Drug Updates
  • 1 comment

FDA approved Radicava (edaravone) for amyotrophic lateral sclerosis

Read more
  • MedWatch Drug Updates
  • 1 comment

Safety alert against LeadCare Testing Systems by Magellan Diagnostics due to inaccurate test results

Read more
  • MedWatch Drug Updates
  • 1 comment

Use of Medtronic’s NavLock Tracker with non-Medtronic instruments can cause spinal injury or death

Read more
  • MedWatch Drug Updates
  • 1 comment

Recall of Coronary Catheters by Abbott due to difficulty in removing the protective balloon sheath

Read more
  • FDA Drug Updates
  • 1 comment

FDA approved Rydapt (midostaurin) for acute myeloid leukemia

Read more
  • FDA Drug Updates
  • 1 comment

FDA expands approved use of Stivarga (regorafinib) for liver cancer

Read more
  • FDA Drug Updates
  • 1 comment

FDA approved Brineura (cerliponase alfa) for Batten disease

Read more
  • MedWatch Drug Updates
  • 1 comment

Recall of 25% Dextrose Injection, USP, (Infant) by Hospira- Presence of particulate matter

Read more
  • MedWatch Drug Updates
  • 1 comment

Recall of GEC Laxoplex dietary supplement by Genetic Edge Compounds- Contaminated with anabolic steroids

Read more
  • FDA Drug Updates
  • 1 comment

FDA approved Ingrezza (valbenazine) for tardive dyskinesia

Read more
  • MedWatch Drug Updates
  • 1 comment

Class I Recall of ventricular assist device controllers and DC adapter by Medtronic Mechanical Circulatory Support

Read more
  • MedWatch Drug Updates
  • 1 comment

Recall of the Wingman35 Crossing Catheters by ReFlow Medical- Tip splitting resulted in adverse events

Read more
  • FDA Drug Updates
  • no comment

FDA approved Ocrevus (ocrelizumab) for multiple sclerosis

Read more
  • FDA Drug Updates
  • 1 comment

FDA approved Zejula (niraparib) for recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer

Read more
  • FDA Drug Updates
  • 1 comment

FDA approves Dupixent (dupilumab) for atopic dermatitis

Read more
  • FDA Drug Updates
  • 1 comment

FDA approved Bavencio (avelumab) for Merkel cell carcinoma

Read more
  • FDA Drug Updates
  • 1 comment

FDA approved Xadago (safinamide) for Parkinson’s disease

Read more
  • MedWatch Drug Updates
  • 1 comment

Drug safety alert: New warning on use of anesthetic/sedation drugs in young children, pregnant women

Read more
  • MedWatch Drug Updates
  • 1 comment

FDA warning- Illegal selling of products that fraudulently claim to prevent, diagnose, treat or cure cancer

Read more
  • MedWatch Drug Updates
  • 1 comment

Recall of Phenobarbital tablets, USP, 15 mg by C.O. Truxton- Mislabeling with incorrect strength

Read more
  • FDA Drug Updates
  • 1 comment

FDA approved Odactra for house dust mite allergies

Read more
  • FDA Drug Updates
  • 1 comment

Approval of Xermelo (telotristat ethyl) for carcinoid syndrome diarrhea

Read more
  • MedWatch Drug Updates
  • 1 comment

FDA restricts use of codeine and tramadol in children and breastfeeding women-Risk of serious adverse reactions

Read more
  • FDA Drug Updates
  • 1 comment

FDA approves Siliq (brodalumab) for psoriasis

Read more
  • FDA Drug Updates
  • 1 comment

FDA approved Parsabiv (etelcalcetide) for hyperparathyroidism in dialysis patients

Read more